A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of
niraparib in ovarian cancer patients who have received three or four previous chemotherapy
regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once
daily continuously during a 28-day cycle. Health-related quality of life will be measured by
Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will
be assessed by clinical review of adverse events (AEs), physical examinations,
electrocardiograms (ECGs), RECIST tumour assessments and safety laboratory values.
View this trial on ClinicalTrials.gov
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